CN219501199U

CN219501199U - Developing structure and bone surgery tool navigation device

Info

Publication number: CN219501199U
Application number: CN202222980572.3U
Authority: CN
Inventors: 郭楚; 徐晓龙; 何智圣; 张柳云; 陈德方; 刘梦星
Original assignee: Wuhan Mindray Technology Co Ltd
Current assignee: Wuhan Mindray Technology Co Ltd
Priority date: 2022-03-04
Filing date: 2022-11-09
Publication date: 2023-08-11
Anticipated expiration: 2032-11-09
Also published as: WO2023165158A1; CN116887776A; CN116740309A; CN116887775A; CN116740309B; CN116687437A; WO2023165157A1

Abstract

The application relates to a developing structure and an orthopedic operation tool navigation device. A developing structure includes a body. The body is provided with a mounting part and at least one position mark, and the at least one position mark is distributed around the mounting part. The location identity can be visualized visually in the medical image. The installation part is used for detachably connecting the navigation module, and the navigation module is used for navigating the orthopedic operation tool. By utilizing the developing structure, subjective qualitative judgment of doctors can be converted into objective quantitative measurement, and the needle inserting precision of the guide needle which is driven for the first time can be improved.

Description

Developing structure and bone surgery tool navigation device

Technical Field

The application relates to the technical field of medical appliances, in particular to a developing structure and an orthopedic operation tool navigation device.

Background

In bone surgery, whether the positioning during the surgery is accurate will directly affect the success or failure of the surgery. In the related art, X-ray assisted positioning planning is generally adopted before operation, and surgical instruments guided by a mechanical mechanism are adopted for manual estimation and adjustment in operation, but the mode is seriously dependent on experience of an operator, and the needle inserting precision of a guide needle for establishing a main nail channel of an intramedullary nail driven for the first time is difficult to control.

Disclosure of Invention

Based on this, it is necessary to provide a visualization structure and an orthopedic operation tool navigation device for the problem that the needle insertion accuracy of the guide needle for establishing the main nail passage of the intramedullary nail is difficult to control for the first time.

According to an aspect of the present utility model, there is provided a developing structure including a body. The body is provided with a mounting part and at least one position mark, and the at least one position mark is distributed around the mounting part. The location identity can be visualized visually in the medical image. The installation part is used for detachably connecting the navigation module, and the navigation module is used for navigating the orthopedic operation tool.

In one embodiment, the position indicator comprises an angular scale, at least one angular scale being distributed around the mounting portion.

In one embodiment, the body is provided with a plurality of angle scales, and the plurality of angle scales comprise reference angle scales and non-reference angle scales arranged on at least one side of the reference angle scales. The non-reference angle scale includes a positive angle scale and/or a negative angle scale.

In one embodiment, the mounting portion and the plurality of angle scales are disposed on the first surface of the body.

In one embodiment, the mounting portion includes a mounting slot in which the navigation module is at least partially received.

In one embodiment, the mounting slot includes a bottom wall parallel to the first surface and a side wall connected to the bottom wall, and the navigation module is removably connected to the bottom wall of the mounting slot.

In one embodiment, the navigation module is clamped in the mounting groove.

In one embodiment, the navigation module is provided with a first magnetic attraction piece, the mounting groove is provided with a second magnetic attraction piece corresponding to the first magnetic attraction piece, and the navigation module is magnetically attracted and connected with the developing structure by means of the first magnetic attraction piece and the second magnetic attraction piece.

In one embodiment, the pattern formed by the projection of the mounting groove in a plane parallel to the first surface is an axisymmetric pattern, and the symmetry axis of the axisymmetric pattern is arranged in line with the extension line of the projection of the reference angle scale in the first surface.

In one embodiment, the outer periphery of the body is provided with an arc-shaped edge connected with the first surface, and the plurality of angle scales are distributed at intervals along the extending direction of the arc-shaped edge.

In one embodiment, the body includes a second surface disposed opposite the first surface, wherein the first surface and the second surface are configured to be planar and parallel to each other.

In one embodiment, the material of the location identifier comprises tantalum.

In one embodiment, the orthopedic surgical tool includes at least one of a guide pin, a holder, and an electric drill.

In one embodiment, the navigation module is used for navigating the intramedullary nail insertion point.

According to another aspect of the present application, there is also provided a navigation device for an orthopedic operation tool, including the above-mentioned visualization structure, and a navigation module. The navigation module comprises an indication component which is used for indicating the relative position information between the current position where the navigation module is positioned and the reference position where the navigation module is positioned in advance. When the navigation module is at the reference position, the navigation module is detachably connected with the developing structure through the mounting part.

In one embodiment, the location identifier comprises an angle scale; the navigation module is provided with an angle sensor for indicating the deviation angle between the current position and the reference position; and/or

The navigation module is provided with a displacement sensor for indicating a relative displacement between its current position and a reference position.

In one embodiment, the angle scale comprises a reference angle scale, and the navigation module is provided with an initial position mark, wherein the initial position mark is aligned with the reference angle scale at the reference position.

In one embodiment, the orthopedic operation tool comprises a guide pin, and the navigation module is provided with a fixing part for installing the guide pin, so that when the guide pin is installed on the fixing part, the extending direction of the guide pin is parallel to the extending direction of the initial position mark.

In one embodiment, the orthopedic tool includes a holder and a drill. The navigation module is magnetically connected with one of the holder and the electric drill, so that the guide pin is arranged in one of the holder and the electric drill, and the extending direction of the guide pin is parallel to the extending direction of the initial position mark.

In one embodiment, the navigation module includes an inertial sensor for indicating an angle of departure and/or a relative displacement between a current position at which the navigation module is located and a reference position.

In one of the embodiments, the navigation module is provided with a level for indicating the pitch angle of the plane in which it lies relative to the horizontal plane.

In one embodiment, the indication assembly comprises a display assembly for displaying relative position information, the relative position information comprising an angle of departure between a current position at which the navigation module is located and a reference position, a relative displacement between the current position at which the navigation module is located and the reference position, and/or a pitch angle of a plane at which the navigation module is located relative to a horizontal plane.

When the development structure and the navigation device for the orthopedic operation tool are used, the body can be detachably connected with the navigation module through the mounting part and placed above the to-be-operated position of the to-be-operated target, so that the position mark and the to-be-operated position can be visually displayed in the medical image, and the mark corresponding to the to-be-operated position on the position mark can be determined according to the medical image. If the position of the navigation module when being connected with the developing structure is set as the reference position, the relative position information between the reference position and the target needle inserting position of the guide needle can be obtained according to the identification corresponding to the position to be operated on the position identification determined by the medical image, and the guide needle in the orthopedic operation tool can be driven into the position to be operated along the target needle inserting position by utilizing the navigation module according to the relative position information. It can be understood that with the development structure, subjective qualitative judgment of doctors can be converted into objective quantitative measurement, and needle insertion accuracy of guide needles which are driven for the first time can be improved.

Drawings

FIG. 1 shows a schematic structural view (first view) of an orthopedic tool navigation device according to an embodiment of the present application;

FIG. 2 shows a schematic structural view (second view) of an orthopedic tool navigation device according to an embodiment of the present application;

FIG. 3 shows an image of an orthopedic tool navigation device and a site to be operated under X-ray perspective in an embodiment of the present application;

FIG. 4 illustrates a top view of an orthopedic surgical tool navigation device positioned over a surgical site of a target to be operated on in an embodiment of the present application;

FIG. 5 is a schematic diagram of a navigation module and a guide pin according to an embodiment of the present application;

figure 6 shows a schematic diagram of the navigation module and drill in an embodiment of the application;

FIG. 7 is a schematic diagram of a navigation module according to an embodiment of the present application;

FIG. 8 illustrates a side view of a navigation module in an embodiment of the application;

FIG. 9 illustrates a top view of a navigation module in an embodiment of the application;

FIG. 10 is a schematic view showing the deviation angle of a navigation module between a reference position and a current position in a navigation device for an orthopedic tool according to an embodiment of the present application;

FIG. 11 is a schematic view showing a height difference between a reference position and a current position of a navigation module in a navigation device for an orthopedic surgical tool according to an embodiment of the present application;

FIG. 12 is a schematic view showing the pitch angle of a navigation module in a navigation device for an orthopaedic surgical tool according to one embodiment of the present application;

FIG. 13 illustrates a schematic diagram of an orthopedic tool navigation device according to an embodiment of the present application when determining a position of a feed point;

fig. 14 shows a schematic diagram of an orthopedic surgical tool navigation device according to an embodiment of the present application when determining the offset angle of the nail feeding point.

In the figure: 10. a navigation device for orthopedic operation tools; 100. developing structure; 110. a body; 1101. a first surface; 1102. an arc edge; 1103. a second surface; 111. a mounting part; 120. a position mark; 200. a navigation module; 210. an initial position mark; 220. a display assembly; 300. an orthopedic surgical tool; 310. a guide pin; 320. an electric drill.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. The present application may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the application, whereby the application is not limited to the specific embodiments disclosed below.

In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. initial positional references are based on the positional references shown in the drawings for convenience of description and simplicity of description only, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the application.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances.

In the present application, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature "above," "over" and "on" a second feature may be a first feature directly above or obliquely above the second feature, or simply indicate that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.

It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.

In bone surgery, whether the positioning during the surgery is accurate will directly affect the success or failure of the surgery. For example, proximal fractures of the femur, such as intertrochanteric fractures, and diaphyseal fractures of the tibia, humerus, etc., are often treated with intramedullary nails to facilitate fracture healing. The position of the intramedullary nail feeding point and the selection of the nail feeding direction are important in the implementation process of the whole operation. Because advance nail position and advance nail direction and can influence the establishment of later stage expanded marrow passageway to and the position and the direction that the main nail of intramedullary nail put into, consequently, the improper selection can lead to the main nail to be difficult to get into the marrow chamber, even can knock into the marrow chamber by force, also can lead to the main nail to be uneven and warp great in the marrow intracavity atress, destroys the fracture reduction effect easily this moment, and the main nail is the condition that far-end locking nail is inaccurate more easily takes place when being long main nail, still can lead to fracture department delay healing even non-healing or deformity healing when serious.

In order to better select the needle insertion point, a doctor is generally required to hold the guide needle by hand and push the tip of the guide needle against the selected needle insertion point before driving the guide needle, at this time, a C-arm X-ray fluoroscopy is performed, and the position of the needle point of the guide needle and the direction of the guide needle are checked on an image, but this method can certainly increase the radiation amount received by the doctor.

The other mode is that after the doctor estimates the needle inserting point by touching the vertex of the greater trochanter, a guide needle is firstly driven in, the guide needle is driven in by bare hand, the holder is used for insertion, the electric drill is used for drilling, and the like, the position of the needle inserting point and the direction of the needle inserting are confirmed according to the perspective image, if the needle inserting point on the righting sheet is positioned at the vertex of the greater trochanter and the included angle between the guide needle and the axis of the femoral shaft is about 5 degrees, the guide needle on the lateral sheet is approximately overlapped with the axis of the femoral neck, and the needle inserting point position and the needle inserting direction are ideal at the moment. If the needle insertion position and the needle insertion direction are not ideal, a doctor estimates the position and the angle to be adjusted through the perspective image, drives in the second guide needle under the condition of not pulling out the first guide needle, and perspectively checks the needle insertion position and the needle insertion direction of the second guide needle again, so that the satisfactory needle insertion position and the satisfactory needle insertion direction are found directly and repeatedly.

However, in the above manner, the accuracy of inserting the guide pin for setting up the main nail channel of the intramedullary nail, which is driven for the first time, is difficult to control, depending on the experience of the operator, and the adjustment process performed according to the result of the fluoroscopy in the later stage greatly prolongs the operation time and increases the number of times of fluoroscopy and the radiation amount of the target to be operated and the doctor.

Fig. 1 shows a schematic structural view of an orthopedic tool navigation device 10 in an embodiment of the present application. The bone surgery tool navigation device 10 comprises a visualization structure 100 and a navigation module 200.

In some embodiments, referring to fig. 1 in combination with fig. 2 and 3, a developing structure 100 according to an embodiment of the present application includes a main body 110. The body 110 is provided with a mounting portion 111 and at least one position identifier 120, and the at least one position identifier 120 is distributed around the mounting portion 111.

The location identifier 120 can be visually displayed in the medical image, the mounting portion 111 is used for detachably connecting with the navigation module 200, and the navigation module 200 is used for navigating the orthopedic operation tool 300. When in use, the body 110 can be detachably connected with the navigation module 200 through the mounting part 111, and the body 110 is placed above the to-be-operated position of the to-be-operated target, so that the position mark 120 and the to-be-operated position can be visually displayed in the medical image, and the mark corresponding to the to-be-operated position on the position mark 120 can be determined according to the medical image. If the position of the navigation module 200 when connected with the visualization structure 100 is set as the reference position, the relative position information between the reference position and the target needle insertion position of the guide needle 310 can be obtained according to the identification corresponding to the to-be-operated position on the position identification 120 determined by the medical image, and the guide needle 310 in the orthopedic operation tool can be driven into the to-be-operated position along the target needle insertion position by using the navigation module 200 to navigate the orthopedic operation tool 300 according to the relative position information, so that the guide needle 310 in the orthopedic operation tool can be driven into the to-be-operated position along the target needle insertion position under the navigation of the navigation module 200 to determine the target needle insertion position of the guide needle 310. It will be appreciated that with the visualization structure 100, subjective qualitative determinations by a physician can be converted to objective quantitative measurements, which can improve the accuracy of insertion of the first-inserted lead 310.

The above-mentioned "medical image" includes, but is not limited to, X-ray fluoroscopic images, nuclear magnetic resonance imaging, and the like. The above-described "medical image" may be imaged under X-rays, high frequency RF propagation and external magnetic fields, ultrasound or gamma rays, or may be imaged in other ways, without limitation.

Illustratively, the position of the navigation module 200 when connected to the visualization structure 100 may be set as a reference position, and the reference position may be set as a zero position of the navigation module 200, so as to facilitate moving the guide pin 310 to its target needle insertion position under the navigation of the navigation module 200.

The navigation module 200 is detachably connected to the developing structure 100, and illustratively, the navigation module 200 and the developing structure 100 may be connected by a manner such as clamping, bonding, magnetic attraction, etc., so as to facilitate the installation and the removal of the navigation module 200 and the developing structure 100. Of course, the navigation module 200 may be detachably connected to the developing structure 100 by other manners besides clamping, bonding, and magnetic attraction, which is not particularly limited herein.

The intramedullary nails at different positions, such as femur, tibia, humerus intramedullary nail and the like, have similar positioning nail-entering points, and the bone surgery positioning method is elaborated by taking the proximal intramedullary nail surgery of femur as an example.

In particular, in the embodiment shown in fig. 3, the to-be-operated portion of the to-be-operated target is a femur, before the operation, the developing structure 100 may be placed on the to-be-operated target, and the information such as the specific position and angle of the femur may be checked by using the X-ray perspective image, so that the relative position information of the reference position and the target needle insertion position of the guide needle 310 may be obtained. The target needle insertion position of the guide needle 310 includes a target needle insertion direction, the reference position includes a reference direction, and the target needle insertion direction is taken as an example to describe that the relative angle θ between the reference direction and the target needle insertion direction of the guide needle 310 can be obtained under the X-ray perspective image ₀ So that the navigation module 200 is used for navigation of the target needle insertion position of the guide needle 310.

Specifically, the identification corresponding to the axis of the femoral shaft on the position identification 120 can be determined under the X-ray perspective image, and in a normal case, the ideal needle inserting direction is the direction of 5 degrees of the axis of the femoral shaft, so that according to the identification corresponding to the axis of the femoral shaft on the position identification 120 and 5 degrees of the axis of the femoral shaft, the target needle inserting direction of the guide needle 310 can be determined under the navigation of the navigation module 200, the accuracy of the needle inserting direction of the guide needle 310 which is driven for the first time can be improved, the perspective times and the radiation amount of a target to be operated and a doctor can be reduced to a certain extent, and the operation time can be shortened.

In order to facilitate the operation, the target to be operated and the portion to be operated are generally kept horizontal, the operation is also performed in a horizontal plane, the patient is usually positioned in a supine position in the proximal femur intramedullary nail operation, the visualization structure 100 is placed on the proximal femur surface of the affected side before the guide pin 310 is driven after the skin incision, the visualization structure 100 is kept relatively horizontal, and the relative angle θ between the target needle insertion direction and the reference direction of the guide pin 310 can be obtained by using the X-ray perspective image ₀ The orthopaedic tool 300 is then deflected by θ relative to the reference direction under navigation by the navigation module 200 ₀ (the orthopedic tool 300 is kept horizontal during deflection), and the guide pin 310 in the orthopedic tool 300 can be arranged approximately horizontally and advanced along the targetThe needle direction is driven into the part to be operated, so that the accuracy of the needle direction of the guide needle 310 driven for the first time can be improved, the perspective times and the radiation quantity of the target to be operated and a doctor can be reduced to a certain extent, and the operation time is shortened.

Alternatively, the position identifier 120 may be integrally formed with the body 110, or may be formed separately and then connected to each other, which is not particularly limited herein.

The developing structure 100 can assist a doctor to quickly and accurately acquire the target nail feeding direction of the main nail of the intramedullary nail, provide a 'measuring scale' for measuring the specific anatomical structure of a real human body, and change subjective qualitative judgment of the doctor into objective quantitative measurement.

In some embodiments, optionally referring to fig. 1 and 2, the location identifier 120 includes an angular scale, at least one angular scale being distributed around the mounting portion 111. Before an operation, the developing structure 100 may be disposed on a target to be operated, and information such as a specific position and an angle of the target to be operated may be checked by using a medical image (such as an X-ray perspective image), and the target needle insertion direction of the guide needle 310 may be more easily found with reference to an angle scale, so that the guide needle 310 is disposed substantially horizontally and driven into the target needle insertion direction under the navigation of the navigation module 200.

In some embodiments, the body 110 is provided with a plurality of angle scales, the plurality of angle scales including a reference angle scale, and a non-reference angle scale disposed on at least one side of the reference angle scale, the non-reference angle scale including a positive angle scale and/or a negative angle scale.

Thus, the positive angle scale or the negative angle scale can be conveniently read as required, the reference angle scale can be used as a reference, the positive angle scale or the negative angle scale corresponding to the part to be operated in the plurality of angle scales can be found out, the corresponding angle scale can be more conveniently read, and the target needle inserting direction of the guide needle 310 can be more conveniently found out.

The angle scale corresponding to the axis of the femoral shaft among the plurality of angle scales can be determined under the X-ray perspective image, and then the target needle inserting direction of the guide needle 310 can be found out according to the angle scale. In particular as shown in FIG. 1In the embodiment shown in fig. 3, the reference angle scale is a 0 ° scale mark, and the positive and negative angle scales are located on either side of the 0 ° scale mark. The target needle insertion direction of the guide needle 310 is the direction deviated 5 degrees from the 20-degree scale mark, so as to obtain θ ₀ Is 20 ° +5° =25°, the lead 310 may be deflected θ relative to a reference direction under navigation by the navigation module 200 ₀ (25 °) and thus enables the guide pin 310 to be disposed substantially horizontally and driven into the site to be operated in its target needle insertion direction (a direction offset by 5 ° from the 20 ° graduation mark).

In some embodiments, the non-reference angle scale includes positive and negative angle scales symmetrically arranged on both sides of the reference angle scale with the reference angle scale as a reference. Thus, the target needle insertion direction of the guide needle 310 can be more conveniently found.

Of course, the distribution of the plurality of angle scales may be other arrangements for facilitating the reading of the angle scales, which is not particularly limited herein.

In some embodiments, referring to fig. 1 and 2, the mounting portion 111 and the plurality of angle scales are disposed on the first surface 1101 of the body 110, so that the navigation module 200 disposed on the mounting portion 111 can conveniently navigate the needle insertion point of the guide needle with reference to the angle scales. Specifically, the direction of the reference angle scale is taken as the reference direction, and the target needle inserting direction of the guide needle 310 is found by taking the reference angle scale as the reference, so that the guide needle 310 can be more conveniently driven into the to-be-operated position along the target needle inserting direction under the navigation of the navigation module 200.

In some embodiments, referring to fig. 1 and 2, the mounting portion 111 includes a mounting slot in which the navigation module 200 is at least partially received.

The navigation module 200 may be placed in the mounting groove, so that the navigation module 200 is convenient to be used in cooperation with the developing structure 100, and it may be understood that a plurality of angle scales surround the mounting groove, so that the navigation module 200 can better determine the target needle insertion direction of the guide needle 310 by taking the direction of the reference angle scale as the reference direction.

In some embodiments, referring to fig. 1 and 2, the mounting slot includes a bottom wall parallel to the first surface 1101 and a side wall connected to the bottom wall, and the navigation module 200 is detachably connected to the bottom wall of the mounting slot.

In this manner, the navigation module 200 may be mounted in the mounting slot so that the navigation module 200 is used with the development structure 100.

Alternatively, the projection of the side wall in a plane parallel to the first surface 1101 is configured as a closed curve.

In some embodiments, the navigation module 200 is clamped in the mounting groove, so that the navigation module 200 can be connected with the developing structure 100 in a clamping manner, the structure is relatively simple, and the installation and the disassembly of the navigation module 200 and the developing structure 100 are more convenient. At this time, the plurality of angle scales are arranged around the mounting groove, so that when the navigation module 200 is mounted in the mounting groove, the navigation module 200 is also convenient to correspond to one of the plurality of angle scales, and the use is more convenient by taking the corresponding one as a reference.

In some embodiments, the navigation module 200 is provided with a first magnetic attraction member, the mounting groove is provided with a second magnetic attraction member corresponding to the first magnetic attraction member, and the navigation module 200 is magnetically connected with the developing structure 100 by means of the first magnetic attraction member and the second magnetic attraction member. The connection reliability of the navigation module 200 and the developing structure 100 can be improved, so that the navigation module 200 is firmly positioned in the mounting groove, which is beneficial to improving the accuracy of the obtained relative position information between the reference position and the needle insertion position of the needle insertion target. In some embodiments, referring to fig. 1 and 2, the projection of the mounting groove in a plane parallel to the first surface 1101 forms an axisymmetric pattern. The symmetry axis of the axisymmetric pattern is arranged co-linearly with the extension line of the projection of the reference angle scale in parallel to the first surface 1101.

It can be understood that the navigation module 200 installed in the installation groove can be centered with respect to the reference angle scale, so that the navigation module 200 can more conveniently use the direction of the reference angle scale as the reference direction, and the developing structure 100 can also find the target needle inserting direction of the guide needle 310 with respect to the reference angle scale, so that the subsequent guide needle 310 can be adjusted with respect to the reference direction under the navigation of the navigation module 200, and further the target needle inserting direction of the guide needle 310 can be determined.

In some embodiments, referring to fig. 1 and 2, an arc-shaped edge 1102 connected to the first surface 1101 is disposed on the outer periphery of the body 110, and a plurality of angle scales are disposed at intervals along the extending direction of the arc-shaped edge 1102.

Thus, any angle scale can be conveniently read according to the requirement. Illustratively, the distribution of the plurality of angular scales is in a fan-shaped arrangement, similar to the distribution of the angular scales of a protractor.

In some embodiments, referring to fig. 1 and 2, the arcuate edge 1102 is configured in an arc shape, so that a plurality of angle scales are distributed in a circumferential array around the center of the arcuate edge 1102.

In some embodiments, referring to fig. 1 in combination with fig. 4, the body 110 includes a second surface 1103 disposed opposite the first surface 1101, wherein the first surface 1101 and the second surface 1103 are configured to be planar and parallel to each other. In this manner, the body 110 can be placed over the site to be operated on of the target to be operated on by means of the second surface 1103. The second surface 1103 can be used to make the developing structure 100 be more stably placed on the proximal surface of the femur on the affected side, so as to better ensure that the developing structure 100 keeps a relative level, and the position mark 120 and the medical image of the developing structure 100 can be used to more accurately obtain the relative position information of the reference position and the target needle insertion position of the guide needle 310.

The second surface 1103 may be a continuous plane or may be composed of a plurality of planes independent of each other, and is not particularly limited herein.

In some embodiments, the material of the location identifier 120 includes tantalum, specifically, the location identifier 120 is made of tantalum wire, so that the location identifier 120 can be visually visualized in a medical image (such as a fluoroscopic image), and thus, the identifier corresponding to the to-be-operated portion on the location identifier 120 can be determined under the medical image (such as a fluoroscopic image), so as to obtain the relative position information of the reference position and the target needle insertion position of the guide needle 310.

Alternatively, the body 110 is made of a light-transmitting material, so that the body 110 made of the light-transmitting material is not developed under the irradiation of X-rays, and does not affect the line of sight, and the body 110 is made of a carbon fiber material, for example.

Alternatively, the development structure 100 may be a rigid structure or a flexible structure, without limitation. Illustratively, the developing structure 100 is a flexible sticker integrated with a plurality of angle scales (the angle scales may be developing wires), and the back surface of the flexible sticker is designed with a glue structure, which can be adhered to any position visible in perspective, such as human skin, an operating table, a C-arm, and the like.

In some embodiments, the orthopedic tool 300 includes at least one of a guide pin 310, a holder, and a drill 320.

The orthopaedic surgical tool 300 and the navigation module 200 may be moved together such that the guide pin 310 is driven into the site to be operated according to the target needle insertion position under the navigation of the navigation module 200.

Referring to fig. 5, a guide pin 310 may be fixed to the navigation module 200, and the guide pin 310 may be driven into the portion to be operated according to the target needle insertion position by means of the navigation bare hand of the navigation module 200; referring to fig. 6, the navigation module 200 may also be directly mounted on the holder or the electric drill 320 by magnetic attraction, and the guide pin 310 is driven into the to-be-operated position by the holder or the electric drill 320 according to the target needle insertion position; other ways of moving the orthopaedic surgical tool 300 and the navigation module 200 together may also be used, without particular limitation.

In some embodiments, the guide pin 310 may be driven into the site to be operated according to the desired needle insertion point under the navigation of the navigation module 200, and as described above, the guide pin 310 is used to establish the main intramedullary nail channel, it will be appreciated that the navigation module 200 may be used to navigate the intramedullary nail insertion point.

In some embodiments, referring to fig. 1 and 2, an orthopedic tool navigation device 10 according to an embodiment of the present application includes the above-mentioned visualization structure 100 and the navigation module 200.

Referring to fig. 7-9, the navigation module 200 includes an indication component for indicating relative position information between a current position of the navigation module 200 and a reference position of the navigation module 200. Wherein the navigation module 200 is detachably connected to the developing structure 100 through the mounting portion 111 when in the reference position.

The visualization structure 100 is used to assist, cooperate with the navigation module 200 to better utilize the navigation module 200 to determine a target needle insertion position of the guide needle 310. Specifically, during use, the position identifier 120 can perform an identifying function on the navigation module 200 and the position information of the to-be-operated site, so as to obtain, under the medical image, relative position information between the reference position and the target needle insertion position, for example, a distance between the reference position and the target needle insertion position, an included angle between the reference position and the target needle insertion position, and the like.

The navigation module 200 is used for realizing the functions of positioning and navigation, and the navigation module 200 is used for indicating the relative position information between the current position of the navigation module 200 and the reference position of the navigation module 200. For example, the navigation module 200 may obtain the position information when the navigation module is at the reference position and the position information when the navigation module is at the current position, and calculate the relative position information between the current position and the reference position by combining the two position information. The navigation module 200 may also record a position change generated when the navigation module itself moves from the reference position to the current position, and calculate the relative position information between the current position and the reference position through the position change. The above positional information, relative positional information, and the like include, but are not limited to, angle information, displacement information, coordinate information, and the like.

In order to facilitate the operation of the navigation module 200, the reference position of the navigation module 200 may be set to a zero position, i.e. the recorded data of the navigation module 200 is zeroed when the navigation module 200 is at the reference position, so that when the navigation module 200 moves to the current position, the relative position information between the current position and the reference position is conveniently and directly obtained.

When the bone surgery tool navigation device 10 is used, the body 110 is detachably connected with the navigation module 200 through the mounting part 111, at this time, the navigation module 200 is located at a reference position, and the body 110 is placed above a to-be-operated position of a to-be-operated target, so that both the position mark 120 and the to-be-operated position can be visually displayed in a medical image, and relative position information between the reference position and the target needle insertion position can be obtained according to the medical image. Then, since the navigation module 200 can indicate the relative position information between the current position and the reference position, the navigation module 200 is moved only under the indication of the navigation module 200, and when the relative position information indicated by the navigation module 200 matches with the obtained relative position information between the reference position and the target needle-inserting position, the guide needle 310 can reach the target needle-inserting position of the guide needle 310 under the navigation of the navigation module 200, thereby realizing the positioning in the operation process.

In some embodiments, referring to fig. 1 and 2, the location identifier 120 includes an angle scale, and the navigation module 200 is provided with an angle sensor for indicating the deviation angle between its current location and a reference location.

Referring to fig. 10, the relative position information includes a deviation angle θ between the current position and the reference position where the navigation module 200 is located ₁ When the navigation module 200 is located at the reference position, the relative angle θ between the reference direction and the target needle insertion direction of the guide needle 310 can be obtained under the medical image ₀ . Only under the instruction of the navigation module 200, the navigation module 200 is moved, when the deviation angle θ indicated by the navigation module 200 ₁ And the obtained theta ₀ When the two directions are matched, the target needle inserting direction of the guide needle 310 can be determined, and the direction positioning in the operation process is realized.

In particular, in the embodiment shown in fig. 3 and 4, the developing structure 100 is placed on the proximal surface of the femur on the affected side, at this time, the developing structure 100 is kept relatively horizontal, and the navigation module 200 is connected to the developing structure 100, at this time, the navigation module 200 is located at a reference position, the reference direction of the reference position corresponds to the direction in which the reference angle scale is located (the scale line of the reference angle scale of 0 °), the angle information indicated by the navigation module 200 corresponds to 0 ° (as shown in the left diagram of fig. 10), and the relative angle θ between the reference direction and the target needle-inserting direction of the guide needle 310 can be obtained by using the medical image ₀ (illustratively, as shown in fig. 3, in the X-ray perspective image, the axis of the femoral shaft is parallel to the scale line of 20 degrees, so that the relative angle between the target needle inserting direction and the reference direction can be calculated to be 20+5° =25°, and θ is obtained ₀ =25°), and then, the navigation module 200 may be moved under the direction of the navigation module 200, when guidedDeviation angle θ between current position and reference position indicated by navigation module 200 ₁ And theta ₀ (θ ₀ When the values are consistent with 25 DEG, the direction positioning during the operation can be realized, in particular, the navigation module 200 can be rotated towards the target needle insertion direction until the deviation angle theta between the current position and the reference position indicated by the navigation module 200 ₁ Up to 25 ° (in fig. 10, the deviation angle θ between the current position and the reference position indicated by the navigation module 200 is given) ₁ For example, 18 °) so that the target needle insertion direction of the lead 310 can be determined, directional positioning during surgery is achieved.

In some embodiments, optionally, the navigation module 200 is configured to indicate relative position information between its current position and the reference position, the relative position information including, in addition to the angle information, a relative displacement, and the navigation module 200 is provided with a displacement sensor configured to indicate the relative displacement between its current position and the reference position. The relative displacement between the current position and the reference position of the navigation module 200 can be obtained by the displacement sensor, and at this time, the relative position information indicated by the navigation module 200 includes the relative displacement, so that the navigation module 200 can realize the positioning of the displacement in the surgical procedure. It should be noted that, the relative displacement includes relative displacements between the current position and the reference position along the x-axis, the y-axis, and the z-axis, and specifically, in the embodiment shown in fig. 11, the relative displacement includes a height difference Δ between the current position and the reference position along the z-axis where the navigation module 200 is located.

In some embodiments, the indicating assembly includes an inertial sensor for indicating an angle of departure θ between the current position at which the navigation module 200 is located and a reference position ₁ And/or relative displacement.

1-12, an angle sensor and a displacement sensor in the navigation module 200 can be integrated, and an inertial sensor is used to obtain the deviation angle theta between the current position and the reference position at one time ₁ And the relative displacement between its current position and the reference position.

As previously mentioned, in order to facilitate the operation of the surgery, it is common to keep the target to be operated and the site to be operated horizontal, and at this time, the operation also needs to be performed in a horizontal plane, and in some embodiments, optionally, referring to fig. 12, the navigation module 200 is provided with a level gauge for indicating a pitch angle α of the plane thereof with respect to the horizontal plane. The level gauge arranged on the navigation module 200 is convenient for keeping the navigation module 200 in a horizontal plane, and the pitch angle positioning in the operation process is realized.

As shown in fig. 1, to more intuitively embody the relative position information indicated by the navigation module 200, in some embodiments, the indication component optionally includes a display component 220 for displaying the relative position information. The relative position information includes a deviation angle θ between the current position where the navigation module 200 is located and a reference position ₁ A relative displacement between the current position at which the navigation module 200 is located and a reference position and/or a pitch angle α of a plane at which the navigation module 200 is located with respect to a horizontal plane.

The type, shape, size, installation position, etc. of the display assembly 220 are not limited, so that the display assembly is convenient for a user to observe during actual use.

In some embodiments, the angle scale includes a reference angle scale, and the navigation module 200 is provided with an initial position mark 210, where the initial position mark 210 is aligned with the reference angle scale. The initial position mark 210 can easily align the reference direction of the navigation module 200 at the reference position with the reference angle scale, and can more conveniently obtain the relative angle theta between the reference direction and the target needle inserting direction by means of medical images ₀ And moves it as a guide for the lead 310 (by navigation of the navigation module 200) to the needle insertion target needle insertion position.

In particular, in the embodiment shown in fig. 1-4, as described above, when in use, the developing structure 100 is placed on the proximal surface of the femur on the affected side, the developing structure 100 is kept relatively horizontal, and the navigation module 200 is connected to the developing structure 100, at this time, the navigation module 200 is at the reference position, at this time, the initial position mark 210 is aligned to the reference angle scale, where the reference angle scale is a scale line with an angle scale of 0 °, indicating that the angle information corresponding to the reference position is 0 °, so as to facilitate calculation of the relative position information.

In some embodiments, the navigation module 200 may be mounted on the orthopedic operation tool 300, and then the guide pin 310 is driven into the portion to be operated under the navigation of the navigation module 200, so that the navigation module 200 may be used to locate and navigate the target needle insertion position of the guide pin 310, which is beneficial to the smooth operation process.

In some embodiments, referring to fig. 5, the orthopedic operation tool 300 includes a guide pin 310, and the navigation module 200 is provided with a fixing portion for installing the guide pin 310, so that when the guide pin 310 is installed on the fixing portion, an extending direction of the guide pin 310 can be parallel to an extending direction of the initial position mark 210. In the operation process, the guide pin 310 can be directly installed on the navigation module 200 by means of the fixing part, and the direction of the guide pin 310 is adjusted under the navigation of the navigation module 200 until the deviation angle theta between the current position and the reference position where the navigation module 200 is located ₁ Reaching theta ₀ The guide pin 310 can be driven into the part to be operated along the target needle inserting direction, so that the target needle inserting position of the guide pin 310 can be positioned and navigated by utilizing the navigation module 200 more conveniently, and the smooth operation process is facilitated.

The fixing portion may be a groove disposed at the bottom of the navigation module 200, or may be other fixing structures capable of fixing the guide pin 310 to the navigation module 200, so long as the extending direction of the guide pin 310 can be parallel to the extending direction of the initial position mark 210 when the guide pin 310 is mounted on the fixing portion. There is no particular limitation herein.

In other embodiments, the orthopedic operation tool 300 includes a holder and an electric drill 320, as shown in fig. 6, the navigation module 200 is magnetically connected to one of the holder and the electric drill 320, so that when the guide pin 310 is mounted on one of the holder and the electric drill 320, the extending direction of the guide pin 310 is parallel to the extending direction of the initial position mark 210, and as such, the target needle insertion position of the guide pin 310 can be more conveniently positioned and navigated by using the navigation module 200, which is beneficial to the smooth operation process.

As mentioned above, the intramedullary nails of different positions, such as femur, tibia, humerus intramedullary nail, etc., are positioned in similar situations, and the bone surgery positioning method is described in detail by taking the proximal intramedullary nail surgery of femur as an example.

The patient's usual position in the proximal femur intramedullary nail operation is in the supine position, and the visualization structure 100 is placed on the proximal femur surface on the affected side after the skin incision and before the guide pin 310 is driven in, at which time the visualization structure 100 remains relatively horizontal.

The bottom surface of the navigation module 200 is designed with a contact, and when the contact contacts with a corresponding contact on the developing structure 100, the navigation module 200 is activated. The navigation module 200 is located at the reference position and at the zero position, so that the sensor inside the navigation module can record the current zero position as the moving reference of the navigation module 200, the height difference delta on the display component 220 of the navigation module 200 is displayed as 0, and the angle theta is deviated ₁ Shown as 0 deg., the pitch angle alpha is close to 0 deg..

Referring to fig. 3, a doctor shoots an orthodontic slice of the proximal femur using a C-arm, based on a medical image (such as an X-ray fluoroscopic image), the doctor can select an angle scale parallel to the axis of the femoral shaft from a plurality of angle scales of the visualization structure 100 (in fig. 3, the angle scale parallel to the axis of the femoral shaft is 20 °) and calculate a relative angle θ between a reference direction and a target needle insertion direction of the guide needle 310 according to an ideal needle insertion direction that is a direction of 5 ° outward of the axis of the femoral shaft ₀ ＝25°。

The navigation module 200 is removed and the visualization structure 100 is removed, the navigation module 200 is mounted on the orthopedic operation tool 300, and illustratively, the orthopedic operation tool 300 can use a guide pin 310, here, a guide pin 310 is inserted by hand, for example, a groove is formed at the bottom of the navigation module 200, the guide pin 310 can be directly fixed on the groove, and the guide pin 310 can be driven into a part to be operated under the navigation of the navigation module 200. Of course, the orthopedic operation tool 300 may alternatively use a holder or electric drill 320, and the navigation module 200 may be directly mounted on the holder or electric drill 320 by magnetic attraction (as shown in fig. 6), and the guide pin may be inserted through the holder or electric drill 320 (under the navigation of the navigation module 200).

When the patient lies on his back, the apex ridge contour line of the greater trochanter on the affected side is generally along the vertical direction and can be manually touched by the doctor from the incision. The physician holds the navigation module 200 (the navigation module 200 has the guide pin 310 mounted thereon and the guide pin 310 is in a substantially horizontal state), and the pitch angle alpha value on the display assembly 220 of the navigation module 200 assists the physician in checking whether the guide pin 310 is approximately maintained horizontal.

Referring to fig. 13, the tip of the guide pin 310 is placed on the vertex a of the ridge profile of the vertex of the large rotor closest to the abdomen side, and the navigation module 200 can measure and display the height difference delta of the current position relative to the reference zero position in real time, wherein the height difference delta is shown as 3 by way of example; the tip of the guide pin 310 is then placed on the vertex P closest to the back side of the large rotor vertex ridge profile, the height difference delta of the navigation module 200 is shown as 11 by way of example, the doctor holds the guide pin 310 approximately horizontally so that the tip moves on the large rotor vertex ridge profile, and the height difference delta displayed in real time by the navigation module 200 varies between 3 and 11. If the doctor selects the middle point of the large rotor vertex ridge profile as the needle insertion point, the middle point position K of the large rotor vertex ridge profile can be determined when the height difference delta is displayed as (3+11)/2=7; similarly, if the doctor selects 1/3 of the front part of the ridge profile of the vertex of the greater trochanter as the needle insertion point of the guide needle, the needle insertion point of the guide needle can be determined when the height difference delta is displayed as 5 or 6. Therefore, the scheme can be suitable for the specific requirements of the selection of the nail feeding point positions of different intramedullary nail products.

Keeping the tip of the guide pin 310 at the needle insertion point of the guide pin unchanged, adjusting the angle of the guide pin 310, and measuring and displaying the deviation angle theta of the current position relative to the reference position (in the reference position, corresponding to the scale line with the 0 degree scale of the angle) by the navigation module 200 in real time ₁ . As shown in fig. 3, a relative angle θ between the reference direction and the target needle insertion direction of the guide needle 310 is obtained under the medical image ₀ 25, as shown in FIG. 14, the lead 310 may be deflected from the reference direction toward the target needle insertion direction until θ displayed by the navigation module 200 ₁ Reaching theta ₀ (As shown in FIG. 10, the right graph in FIG. 10 shows θ ₁ For 18 °, the right graph in fig. 10 is a diagram for adjusting the offset angle θ by using the navigation module 200 ₁ Is a schematic diagram of the process of (a)The dotted line in the right graph in fig. 14 is parallel to the initial position mark 210 of the navigation module 200, and the direction corresponding to the dotted line is the reference direction), so that the guide pin 310 can be arranged along the target needle inserting direction, and the direction positioning of the guide pin 310 can be realized. The physician of the leading needle 310 may also adjust the pitch angle α displayed by the navigation module 200 and insert the leading needle 310 after adjusting the pitch angle α appropriately.

It can be seen that the developing structure 100 can assist a doctor to quickly and accurately obtain the target needle direction of the guide needle 310, and can provide real-time guiding of the needle direction for the doctor as a medium for registering the navigation module 200 with the real human body.

The navigation module 200 performs functions such as accurate positioning of the needle insertion direction of the guide needle, quantifies control of the needle insertion point of the guide needle and the target needle insertion direction based on subjective experience of a doctor, and provides the quantified control to the doctor as auxiliary guidance, so that the difficult problem that the needle insertion point cannot be accurately positioned and the needle insertion direction cannot be accurately controlled in clinic is solved.

The orthopedic operation tool navigation device 10 can fundamentally realize the accurate positioning of the needle insertion point and the target needle insertion direction, provide real-time position and angle information for doctors, ensure that the needle 310 is successfully driven once, and do not need to be driven into the needle 310 for adjustment for multiple times. In addition, the orthopedic operation tool navigation device 10 is small and easy to use, can greatly shorten operation time, reduce X-ray radiation quantity of doctors and patients, and improve operation quality and efficiency.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the utility model, which are described in detail and are not to be construed as limiting the scope of the utility model. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the utility model, which are all within the scope of the utility model. Accordingly, the scope of protection of the present utility model is to be determined by the appended claims.

Claims

1. A developing structure, characterized by comprising: a body;

the body is provided with a mounting part and at least one position mark, and the at least one position mark is distributed around the mounting part;

the location identity can be visualized visually in the medical image;

the installation part is used for detachably connecting the navigation module, the navigation module is used for navigating the orthopedic operation tool.

2. The developing structure of claim 1, wherein the position indicator includes an angular scale, at least one of the angular scales being distributed around the mounting portion.

3. A developing structure according to claim 2, wherein said body is provided with a plurality of said angle scales;

the plurality of angle scales comprise reference angle scales and non-reference angle scales arranged on at least one side of the reference angle scales;

the non-reference angle scale comprises a positive angle scale and/or a negative angle scale.

4. A developing structure according to claim 3, wherein the mounting portion and the plurality of angle scales are provided on the first surface of the body.

5. The developing structure of claim 4, wherein the mounting portion includes a mounting slot, the navigation module being at least partially received in the mounting slot.

6. The developing structure according to claim 5, wherein the mounting groove includes a bottom wall parallel to the first surface and a side wall connected to the bottom wall;

the navigation module is detachably connected to the bottom wall of the mounting groove.

7. The developing structure of claim 5, wherein the navigation module is snapped into the mounting slot.

8. The developing structure according to claim 5, wherein the navigation module is provided with a first magnetic attraction member;

the mounting groove is provided with a second magnetic attraction piece corresponding to the first magnetic attraction piece;

the navigation module is magnetically connected with the developing structure by means of the first magnetic attraction piece and the second magnetic attraction piece.

9. The developing structure according to claim 5, wherein a pattern formed by projection of the mounting groove in a plane parallel to the first surface is an axisymmetric pattern;

and the symmetry axis of the axisymmetric graph is arranged in line with an extension line of the projection of the reference angle scale in the first surface.

10. The developing structure according to claim 4, wherein an arc-shaped edge connected to the first surface is provided on an outer periphery of the body, and a plurality of the angle scales are arranged at intervals along an extending direction of the arc-shaped edge.

11. The developing structure according to claim 4, wherein the body includes a second surface disposed opposite to the first surface;

wherein the first surface and the second surface are configured to be planar and parallel to each other.

12. The developing structure of any one of claims 1-11 wherein the material of the location indicator comprises tantalum.

13. The visualization structure of claim 1, wherein the orthopedic surgical tool comprises at least one of a guide pin, a holder, and an electric drill.

14. The visualization structure of claim 1, wherein the navigation module is configured to navigate an intramedullary nail insertion point.

15. A navigation device for an orthopedic surgical tool, comprising:

the development structure of any one of claims 1-14;

the navigation module comprises an indication component, wherein the indication component is used for indicating relative position information between the current position of the navigation module and a reference position of the navigation module in advance;

when the navigation module is positioned at the reference position, the navigation module is detachably connected with the developing structure through the mounting part.

16. The bone surgical tool navigation device of claim 15, wherein the location identifier includes an angular scale; the navigation module is provided with an angle sensor for indicating the deviation angle between the current position and the reference position; and/or

17. The orthopaedic surgical tool navigation device of claim 16, wherein the angle scale includes a reference angle scale;

and the navigation module is provided with an initial position mark, and the initial position mark is aligned with the reference angle scale at the reference position.

18. The orthopaedic surgical tool navigation device of claim 17, wherein the orthopaedic surgical tool comprises a guide pin;

the navigation module is provided with a fixing part for installing the guide pin, so that when the guide pin is installed on the fixing part, the extending direction of the guide pin is parallel to the extending direction of the initial position mark.

19. The orthopaedic surgical tool navigation device of claim 18, wherein the orthopaedic surgical tool includes a holder and an electric drill;

the navigation module is magnetically connected with one of the holder and the electric drill, so that the guide pin is arranged in one of the holder and the electric drill, and the extending direction of the guide pin is parallel to the extending direction of the initial position mark.

20. The orthopaedic tool navigation device of claim 15, wherein the navigation module includes an inertial sensor for indicating an angle of departure and/or a relative displacement between a current position at which the navigation module is located and a reference position.

21. The navigation device of an orthopaedic surgical tool according to claim 15, wherein the navigation module is provided with a level for indicating the pitch angle of its plane relative to the horizontal.

22. The bone surgical tool navigation device of claim 15, wherein the indication component includes a display component for displaying the relative position information;

the relative position information comprises a deviation angle between the current position of the navigation module and the reference position, a relative displacement between the current position of the navigation module and the reference position, and/or a pitch angle of a plane of the navigation module relative to a horizontal plane.